Sai Bhamidipati

CMC Regulatory Leader at Moderna      


Sai Prathyusha Bhamidipati is a seasoned regulatory affairs professional with extensive experience in Chemistry, Manufacturing, and Controls (CMC) within the biopharmaceutical industry. She has held key positions at leading companies, including Moderna, Inc., Vertex Pharmaceuticals, Sage Therapeutics, and Amgen Inc., where she has been instrumental in leading and developing strategies for Biologics License Applications (BLAs) for novel therapeutic products. Sai is recognized for her ability to navigate complex regulatory landscapes and her commitment to advancing regulatory practices.

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Articles from Sai

The Future of Advanced Therapeutics: Opportunities and Challenges

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The Future of Advanced Therapeutics: Opportunities and Challenges

The biopharmaceutical landscape is transforming with the advent of advanced therapeutics, including mRNA vaccines, gene therapies, and personalized medicine. These innovative treatments offer unprecedented opportunities to address complex diseases. Yet, they also present unique regulatory and manufacturing challenges that must be navigated to bring them from the laboratory to the clinic.